510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Darwin Knee System

K943462510(k) TraditionalCleared Dec 21, 1994156-day reviewClass II21 CFR 888.3560Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Johnson & Johnson Professionals, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 21, 1994 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 428 later devices descend from it. It has been recalled 8 times.

Decided
Dec 21, 1994
Review
156 days
Class
Class II
Product code
JWH
Recalls
8
Predicates
0

428 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2006: 4 descendants cleared2004: 2 descendants cleared2015: 27 descendants cleared2020: 34 descendants cleared2024: 40 descendants cleared2008: 4 descendants cleared2003: 1 descendant cleared2010: 6 descendants cleared2019: 34 descendants cleared2017: 16 descendants cleared2011: 10 descendants cleared2009: 5 descendants cleared2005: 1 descendant cleared2021: 39 descendants cleared2012: 6 descendants cleared2007: 2 descendants cleared2014: 12 descendants cleared2026: 38 descendants cleared2013: 12 descendants cleared2016: 19 descendants cleared2023: 34 descendants cleared2025: 36 descendants cleared2018: 16 descendants cleared2022: 30 descendants cleared1990200020102020
  1. This deviceK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994
  2. Descendant · cites it directly · 351 of its ownK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. Descendant · cites it directly · 324 of its ownK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. Descendant · 2 generations on · 158 of its ownK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
  5. Descendant · cites it directly · 120 of its ownK062654 Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006
  6. Descendant · cites it directly · 118 of its ownK032151 Depuy Sigma Tibial Inserts and CO-CR Tibial TraysDepuy, Inc. · 2003 · Recalled

Showing 5 of 428 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 12006: 42007: 22008: 42009: 52010: 62011: 102012: 62013: 122014: 122015: 272016: 192017: 162018: 162019: 342020: 342021: 392022: 302023: 342024: 402025: 362026: 38
2003high 40 (2024) · low 1 (2003)2026

Most influential descendants

Showing 5 of 428 · See all
  • K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · cites it directly351descendants
  • K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · cites it directly324descendants
  • K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005 · 2 generations on158descendants
  • K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006 · cites it directly120descendants
  • K032151Depuy Sigma Tibial Inserts and CO-CR Tibial TraysDepuy, Inc. · 2003 · cites it directly118descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.1994—
+1K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
+1K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
+2K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc.2005—
+1K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc.2006—
+1K032151Depuy Sigma Tibial Inserts and CO-CR Tibial TraysDepuy, Inc.200312

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200510
200640
200720
200840
200950
201060
2011100
201260
2013120
2014120
2015270
2016190
2017160
2018160
2019340
2020340
2021390
2022300
2023340
2024400
2025360
2026380
FIG. 1 — Lineage of K943462, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (428)

See all 428

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.2004351
K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004324
K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc.2006120
K032151Depuy Sigma Tibial Inserts and CO-CR Tibial TraysDepuy, Inc.2003118
K082500Depuy Sigma CR-F Femoral ComponentDePuy Orthopaedics, Inc.2008115
K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010114
K060192Apex Knee SystemOmni Life Science, Inc.2006111
K061648Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc.200661
K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 9, 2013Class IIZ-1077-2014Process designKnee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause…
May 7, 2009Not classifiedZ-1686-2009Process controlThere may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant.
Sep 27, 2007Not classifiedZ-0406-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0402-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0403-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0407-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0404-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0405-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033272 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 351 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

More from Johnson & Johnson Professionals, Inc.

206 FDA decisions under this applicant name. See the company

  • K992173Siphonguard CSF Control DeviceJohnson & Johnson Professionals, Inc. · 2000
  • K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
  • K991222Codman Microsensor Ventricular Catheter KitJohnson & Johnson Professionals, Inc. · 1999
  • K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998
  • K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K943462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943462: Darwin Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943462

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026